Development and Validation of The Japanese Version of The Constitution in Chinese Medicine Questionnaire (CCMQ)

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日東医誌 Kampo Med Vol.59 No.

6 783-792, 2008 783

Original Article

Development and Validation of the Japanese


Version of the Constitution in Chinese
Medicine Questionnaire (CCMQ)
Yanbo ZHUa* Hideki ORIGASAb Kazuo UEBABAc
Fenghao XUc Qi WANGd
a School of Administration, Beijing University of Chinese Medicine, Beijing 100029, China
b Division of Biostatistics and Clinical Epidemiology, University of Toyama School of Medicine and Pharmaceutical Sci-
ences, Toyama 930-0194, Japan
c International Research Center for Traditional Medicine, Toyama 939-8224, Japan
d School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China

体質に関する CCMQ 質問票日本語版の臨床開発とその妥当性の検証


朱 燕波a* 折笠 秀樹b 上馬場 和夫c
許 鳳浩c 王 ! d

a 北京中医薬大学管理学院,中国,北京1
000
29,北京市朝陽区北三環東路1 1号
b 富山大学医学薬学研究部バイオ統計臨床疫学,富山,〒9 3
0‐0
194 富山市杉谷263

c 富山県国際伝統医学センター,富山,〒939
‐822
4 富山市友杉151
d 北京中医薬大学基礎医学院,中国,北京100
029,北京市朝陽区北三環東路1 1号

Abstract
Objectives : The objective of this study is to develop a Japanese version of the Constitution in Chinese Medi-
cine Questionnaire (CCMQ) in Chinese, which is comprised of 60 items with 9 sub-scales, and evaluate its re-
liability and validity. Methods : We conducted a survey of 130 participants in the Toyama area of Japan from
Dec. 2005, to Feb. 2006. A test-retest method was used. Feasibility was evaluated by the response times to
the questionnaire, and the response rates of the CCMQ items. Internal consistency within the sub-scales was
assessed by Cronbach’s α coefficient. Reproducibility was confirmed between the first and second occasions
using weighted kappa and Spearman correlation. Lastly, criterion validity was evaluated by correlation be-
tween CCMQ and SF-36 sub-scales. Results : Response time was 8 minutes on average and its rate was
nearly 100%. Internal consistency was achieved for each of the 9 sub-scales with a 0.65 to 0.79 α coefficient.
Reproducibility ranged from 0.41 to 0.81 for the items, and from 0.79 to 0.88 for the sub-scales. Regarding the
criterion validity, the “Gentleness type” sub-scale was positively correlated with SF-36 (0.46, P<0.001), while
other 8 pathological constitutional types of the CCMQ were negatively correlated with SF-36 (-0.35 to -0.50, P
<0.001) as expected. Conclusions : We developed a Japanese version of the CCMQ and found acceptable lev-
els of reliability and validity using a survey of 130 subjects in Japan. This suggests that the CCMQ could be a
useful tool in comparing the constitution profiles between Chinese and Japanese.
Key words: Constitution, CCMQ, Qi-deficiency type, Yang-deficiency type, reliability, validity

要旨
目的:本研究の目的は中国語版体質に関する質問票(CCMQ)の日本語版を開発することである。この質問票は
全部で6
0問あり,9つの下位尺度(平和質・気虚質・陽虚質・陰虚質・痰湿質・湿熱質・ 血質・気鬱質・特稟質, !
ここで平和質を除く8体質は病理体質)に分けられる。この質問票に対して,信頼性と妥当性を検証することを目
標とする。 方法:2
005年1
2月から2
006年2月にかけて,富山市内の1
30名の住民に対して Test-retest 法を用い
て調査を実施した。質問票の許容性は回答時間と回答率で評価した。内部妥当性は下位尺度ごとにクローンバック
α 係数で検討し,1回目と2回目の回答に関する再現性は重み付けカッパ係数とスペアマン相関係数で検討した。
基準連関妥当性は,本質問票の CCMQ と包括質問票として著名な SF−3
6下位尺度との相関係数で評価した。
結果:回答時間は平均8分であり,回答率はほぼ1
00%であった。9つの下位尺度に関する α 係数は0.
65から0.
79
であった。再現性は各質問につき0.
41∼0.
81であり,下位尺度については0.
79∼0.
88と優れていた。基準連関妥当
性については,予想通り,正常体質である平和質型と SF−3
6とは正の相関を示し(r=0.
46,P<0.
001)
,病的体

*Corresponding author : Yanbo ZHU


Received 18 September 2007, Accepted 11 July 2008
784 日東医誌 Kampo Med Vol.59 No.6. 2008

質である残り8つの体質型と SF−3
6とは負の相関を示した(−0.
35∼−0.
50,P<0.
001)

結論:中国語版体質に関する質問票(CCMQ)の日本語版を開発し,その信頼性と妥当性を1
30名の住民に対し
て立証した。今後,日中間において体質研究を行う際,この質問票は有用な道具になることが期待される。
キーワード:体質,CCMQ 質問票,気虚質,陽虚質,信頼性,妥当性

Ⅰ.Introduction leagues in 2004 to 2005. It was a self-administered


The constitution in Chinese medicine is based on questionnaire comprised from 9 sub-scales of Gen-
an individuals’ inherited constitutions and their life- tleness type, Qi-deficiency type, Yang-deficiency
styles, geographic and climatic environment which type, Yin-deficiency type, Phelgm-wetness type,
are acquired. The constitution greatly affects our Wet-heat type, Blood stasis type, Qi-depression type
health and disease ; therefore it is necessary to make and Special diathesis type. Each sub-scale consisted
a questionnaire to quantify the constitution in a sci- of 7 to 9 individual questions and ended up with 60
entific way. questions. Some of the questions apply to both of
Western medicine has categories like Short and the two sub-scales. For example : Question 2 “Do
Fat type, Thin type and Medium type. In Chinese you get tired easily?” pertains to both the Gentle-
medicine, from ancient to now, there were many ness type and the Qi-deficiency type. The meaning
categories about constitution, in ancient times has of each sub-scale was shown on Table 1. Each
classification of 25 types, in modern times has clas- question was answered by choosing one from the
sifications of 4, 5, 6, 7, 9 and 12 constitution Likert scale on the grade of 5 scales as Never , !
types1)2). Wang’s 9 classification of constitution for " # $
Rarely , Sometimes , Often and Always . In %
general populations from numerous observations for each sub-scale, the points were summed up for each
past few decades was proved to be clinically useful person. Sub-scale summary score was standardized
and also practical. Their categories were classified from 0 to 100 by using the formula as (Sum-Lowest
by Gentleness type(平和質) ,Qi-deficiency type score)/(Highest score-Lowest score) multiplied by
(気虚質) ,Yang-deficiency type(陽虚質) ,Yin- 100. The higher the score was, the stronger the con-
deficiency type(陰虚質) ,Phlegm-wetness type stitution type was.
(痰湿質) ,Wet-heat type (湿熱質) ,Blood-stasis First, a panel of Chinese experts translated the
!
type( 血質) ,Qi-depression type(気鬱質)and CCMQ into Japanese. Then, a pilot survey using it
Special diathesis type(特稟質) . Excluding Gentle- was conducted on the seven subjects. After moder-
ness type, eight of the constitutions are classified ating several problems, a panel translated again it
into pathological constitution(病的体質)types2)∼4). into Japanese. Its version was now reversely trans-
Therefore, based on the concept of 9 sub-scales of lated into Chinese by a different panel of experts.
constitution, Wang and colleagues has developed a Thus, a final Japanese version was completed. A pi-
new questionnaire comprised from 60 questions in a lot survey was now conducted on the seven subjects
standardized way5)∼8). The development of ques- and the quality of the questionnaire was verified and
tionnaire is mainly applied to the health promotion finalized.
and clinical practice especially in traditional Chi- 2.Subjects
nese medicine. It may also be useful in clinical Those who were asked to participate in the survey
evaluation of traditional Chinese medicine and ap- were attendees of utilizing the Health Park con-
plicable for Kampo and other medicines. We se- nected to the International Center for Traditional
lected Wang’s questionnaire since it was well ap- Medicine in Toyama. This survey was conducted
plied shown in above and psychometrically tested. for a total of 130 persons and they were selected
This is the reason that Wang’s questionnaire was considering the balance of age and sex strata. Par-
translated into Japanese through a pilot study. The ticipants were over 20 years of age and written in-
objective of this study is to evaluate the feasibility, formed consent was obtained from each person.
reliability and validity of the Japanese version of Those excluded were :
CCMQ questionnaire using a psychometric test. 1)Those with mental sicknesses and those with
behavioral problems.
Ⅱ.Methods 2)Those with serious illnesses.
1.Development of a Japanese Ver- 3)Those who could not understand the ques-
sion of the CCMQ tionnaire.
The CCMQ was developed by Wang and his col- 4)Those who would not consent to answering
日東医誌 Kampo Med Vol.59 No.6. 2008 785

Table 1 Nine sub-scales of the CCMQ and their meanings

the questionnaire. from all the participants, the questionnaire was con-
3.Contents of the Questionnaire ducted either on a personal interview basis or ex-
! CCMQ – We used the Japanese version of plained over the telephone. The test and re-test
the CCMQ shown in the Appendix to conduct this method was utilized with an interval of one to four
research. weeks on the same contents of the questionnaire.
" QOL Questionnaire – In order to evaluate This study was approved by the University of
criterion validity, we conducted the survey of SF-36 Toyama Ethical Committee in advance.
(Japanese version) which includes physical and 5.Statistical Analysis
mental component summary (abbreviated by PCS Values were presented as mean ± standard devia-
and MCS later) at the same time. Scores rang from 0 tion. Feasibility was evaluated by the response time
to 100, with higher scores indicating better subjec- to the questionnaire and the response rate of each
tive health status9)10). item. Internal consistency was evaluated by Cron-
# Background – We asked age, sex, academic bach’s alpha coefficient for each of the 9 sub-scales.
career, occupation, and marital status of the subject Reproducibility was evaluated by the weighted
at baseline. kappa coefficient for each question and Spearman
4.Design correlation coefficient for each sub-scale. Criterion
This survey was held from December 2005 to validity was assed by the comparison with SF-36,
February 2006. After receiving a written consent PCS and MCS of the SF-36. Statistics Analysis was
786 日東医誌 Kampo Med Vol.59 No.6. 2008

Appendix. Japanese version of the Constitution in Chinese Medicine


Questionnaire (CCMQ)
体質に関する調査票

この調査票はあなたの体質に関する状況を調べ,今後の健康管理
や診療に参考にさせていただく目的で使われるものです。一つ一つ
の項目をよく読んで,最近1年間のあなたの状況や感じに最もよく
あてはまる番号をひとつだけ選び,○で囲んでください。答えにく
い場合には,最も近い状況にあてはまる答えを選んでください。
すべての項目は最近1年間の状況を答えてください。また項目ご
とに,1つだけ○をつけてください。

最近の1年間にあなたが,以下の質問について,どの まった まれに ときど よく いつも


ぐらい経験しましたか くない ある きある ある ある
¸ 元気がありますか 1 2 3 4 5
¹ 疲れやすいですか 1 2 3 4 5
º 息切れをしますか 1 2 3 4 5
どう き
» 動悸(脈拍が早い)がしますか 1 2 3 4 5
¼ めまいや立ちくらみをしますか 1 2 3 4 5
½ 物静かで,人と話すのが苦手のほうですか 1 2 3 4 5
¾ 話し声が弱弱しいですか 1 2 3 4 5
¿ 物忘れをしますか 1 2 3 4 5
ゆううつ
À 憂鬱で,気が沈む感じがしますか 1 2 3 4 5
Á 精神が緊張して,イライラしますか 1 2 3 4 5
かんしょうてき
 感 傷 的で,涙もろいですか 1 2 3 4 5
à 特に理由もなく,恐ろしいと感じますか 1 2 3 4 5
わき
Ä 胸や脇が張ったり,痛んだりしますか 1 2 3 4 5
Å 胸が詰まって重苦しい感じがしますか(特に湿気っ
1 2 3 4 5
ぽい天気時に)
Æ 何の理由もなく,ため息をつきますか 1 2 3 4 5
Ç 体と手足が重だるく感じますか 1 2 3 4 5
È 手のひらと足の裏がほてりますか 1 2 3 4 5
É 夏でも手足が冷えますか 1 2 3 4 5
こし ひざ
Ê 腰や膝が冷えますか 1 2 3 4 5
あつ ぎ
Ë 寒がりで,ほかの人より厚着を好みますか 1 2 3 4 5
Ì 顔や身体のほてりを感じますか 1 2 3 4 5
Í ほかの人より,冬の寒さに弱いですか 1 2 3 4 5
Î ほかの人より風邪を引きやすいですか 1 2 3 4 5
Ï 風邪を引いていないのに,くしゃみが出ますか 1 2 3 4 5
Ð 風邪を引いていないのに,鼻水が出ますか 1 2 3 4 5
はな つ
Ñ 風邪を引いていないのに,鼻詰まりますか 1 2 3 4 5
Ò 暑さ・運動・厚着にかかわらず,汗をかきやすいで
1 2 3 4 5
すか
Ó 汗が出やすく,べっとり感がありますか 1 2 3 4 5
Ô 手のひらと足の裏に,汗をたくさんかきますか 1 2 3 4 5
日東医誌 Kampo Med Vol.59 No.6. 2008 787

最近の1年間にあなたが,以下の質問について,どの まった まれに ときど よく いつも


ぐらい経験しましたか くない ある きある ある ある
Õ 過敏症(薬,食べ物,花粉など)ですか 1 2 3 4 5
じん ま しん
Ö 皮膚に蕁麻疹ができやすいですか 1 2 3 4 5
むらさきいろ はんじょう
× 過敏で,皮膚に紫 色のまだら(点状・斑 状の出血) 1 2 3 4 5
が出ますか
Ø 気がつかないうちに,皮膚に青あざができますか 1 2 3 4 5

Ù 皮膚を "くと赤くなり,"いた跡がつきますか
か か
1 2 3 4 5
Ú 皮膚が乾き気味ですか 1 2 3 4 5
Û 皮膚が荒れやすいですか 1 2 3 4 5
Ü 体のあちこちが痛みますか 1 2 3 4 5
ほお
Ý 顔の頬のあたりが赤い(ほてり)ですか 1 2 3 4 5
Þ 顔や鼻がべとついたり,テカテカに光っていますか 1 2 3 4 5
ß 顔色がさえないですか 1 2 3 4 5
à にきびや吹き出物ができやすいですか 1 2 3 4 5
まぶた
á 瞼がはれぼったいですか 1 2 3 4 5
â 目の下にくまがありますか 1 2 3 4 5
ã 目の乾燥感がありますか 1 2 3 4 5
ä 目が充血しますか 1 2 3 4 5
のど かわ
å 口または咽が渇きますか 1 2 3 4 5
のど
æ 咽に何か詰まっている感じがしますか 1 2 3 4 5
こうしゅう
ç 口の中に口 臭や苦い感じがしますか 1 2 3 4 5
è 口の中がねばつきますか 1 2 3 4 5
é いびきをかきやすいですか 1 2 3 4 5
たん
ê 痰がたくさん出ますか 1 2 3 4 5
ë 冷たいものをとると,体調を悪くしますか 1 2 3 4 5
じゅくすいかん
ì 熟 睡感がありますか 1 2 3 4 5
í 寝つきが悪いですか 1 2 3 4 5
î 下痢をしますか 1 2 3 4 5
ï 大便が粘ついて,排便後,さっぱりしない感じがし
1 2 3 4 5
ますか
ð 大便が硬くて,便秘しやすいですか 1 2 3 4 5
ñ 尿の回数と量は多く,色が薄いですか 1 2 3 4 5
ò 排尿するとき,尿道に熱さを感じ,濃い尿が出ます
1 2 3 4 5

ó おりものの色が黄色いことがありますか(女性のみ
1 2 3 4 5
回答)

ó
いんのう
陰 !が湿っぽい感じがしますか(男性のみ回答) 1 2 3 4 5

あなたは全部の項目を,何分で回答できましたか
約( )分

ご協力ありがとうございました。もう一度記入もれがないかどうか確かめてください。
788 日東医誌 Kampo Med Vol.59 No.6. 2008

Table 2 Basic characteristics of the participants in the study

Table 3 Score distribution of the nine sub-scales of the Japanese CCMQ


日東医誌 Kampo Med Vol.59 No.6. 2008 789

Table 4 Reproducibility of nine sub-scales and sixty questions

performed by SAS 8.2 and JMP 5.0.l J and the sig- were 33.9%. The final academic career being col-
nificant level was set as P<0.05. lege level or higher was 50.8% and others were
49.2% (Table 2). The score of each sub-scale of
Ⅲ.Results CCMQ was shown on Table 3.
The response rate was 96% at the first test and 2.Feasibility
93% at the re-test occasion. Since two subjects did The average time for response was 8 minutes ±
not answer more than 14 questions at the first time 4.2 minutes. The response rates of each of the 60
of test, their data were excluded. Therefore, the re- items varied from 99 to 100%.
sult was shown on the basis of data from a total of 3.Reproducibility (Table 4)
123 subjects. The reproducibility of the Japanese CCMQ varied
1.Background of Subjects 0.79 to 0.88 for each of the 9 sub-scales and 0.41 to
The 123 questionnaires received were from 49 0.81 for each of the 60 questions.
men (39.8%) and 74 women (60.2%). The average 4.Internal Consistency (Table 5)
age was 43.9 years, the youngest was 21 and the The standardized Cronbach’s coefficient varied
oldest was 73 years of age. The questionnaires from from 0.65 to 0.79 for each of the 9 sub-scales.
people in their 40’s were the highest (33.1%) fol- 5.Validity (Table 6)
lowed by people in their 30’s. 75.6% were married, Regarding the criterion validity, the correlation
21.1% were single and 3.3% were others. Concern- coefficient between the 9 sub-scales of the Japanese
ing the occupation, specialists and skilled crafts per- CCMQ and SF-36 was 0.46 for the Gentleness type
sons were highest in number at 37.2%, followed by (P<0.001) and-0.35 to 0.50 (P<0.001) for the rest of
unemployed people 15.7%, clerical and secretarial 8 sub-scales that were recognized by pathological
workers at 12.4%. Executives, salespersons, agri- constitution types.
cultural, fisher, construction workers and students
790 日東医誌 Kampo Med Vol.59 No.6. 2008

Table 5 Cronbach’s alpha coefficients for nine sub-scales

Ⅳ.Discussions the basis upon the fundamental concepts that have


The constitution classification is the basis of tra- been used in traditional Chinese medicine.
ditional Chinese medicine. There was a great need With respect to the feasibility of the Japanese
for a questionnaire to enable for evaluating the con- CCMQ, the average response time was 8 minutes
stitution in a scientifically valid method ; therefore, and the response rate of the 60 items was each 99-
a new standardized questionnaire called CCMQ was 100% which was rather high. It was generally said
developed in Chinese. This questionnaire is clinical to be fair if a weighted kappa coefficient is 0.4-
important in the clinical evaluation of Kampo medi- 0.75 ; and good if it is 0.75 or greater16)∼19). For
cine and health promotion before getting diseases. Spearman correlation, it was said to be good if it
In order to initiate a cross-cultural project of the was 0.6 or greater17)18). In this study, all the data of
constitution types comparing between China and Ja- weighted kappa coefficient were greater than 0.4.
pan, its Japanese version was really necessary to de- Spearman correlation coefficients were greater than
velop. It was developed by a validated linguistic 0.6. Both the results showed good reproducibility
method. for both questions and sub-scales.
This questionnaire involves the constitution types Regarding the internal consistency, it was gener-
of Gentleness(平和) ,Qi-deficiency(気虚) ,Yang- ally said to be good if Cronbach’s coefficient was
deficiency(陽虚) ,Yin-deficiency(陰虚) ,Phlegm- 0.7 or greater16)17)20). In our study, five sub-scales
wetness(痰 湿) ,Wet-heat(湿 熱) ,Blood-stasis such as Yang-deficiency type, Yin-deficiency type,
!
( 血) ,Qi-depression(気鬱)and Special diathe- Wet-heat deficiency type, Blood-stasis type, and
(特稟)
sis .These 9 types of constitution seen in the Special Diathesis type expressed above 0.7 ; how-
CCMQ questionnaire not only based mainly on defi- ever, others expressed less than 0.7. Actually, they
ciency, excess, rise and fall of the Yin-Yang and the were 0.65 for the Gentleness type, 0.65 for the Qi-
Qi, Blood, Body Fluid, but also started from the deficiency type, 0.66 for the Phlegm-wetness type,
view of clinical practices in traditional Chinese and 0.69 for the Qi-depression type. Thus, the inter-
medicine. The constitution classification method has nal consistency for some of the sub-scales was con-
been widely promoted and applied in China11)∼15). sidered to be a little bit low but moderately satisfied.
Thus, the CCMQ questionnaire was constructed on Validity was usually classified by scaling, factor
日東医誌 Kampo Med Vol.59 No.6. 2008 791

Table 6 Criterion validity of the Japanese CCMQ with SF-36 components

or construction, criterion, convergent or divergent Program) (No.2005 CB 523501) and the Nippon
validity. In this study, scaling seemed to be fairly Foundation.
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